Neurocrine nabs Ingrezza OK to kick-start tardive dyskinesia market, with Teva waiting in the wings

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Neurocrine Biosciences' Ingrezza is the first-ever FDA approval in tardive dyskinesia, though Teva's Austedo may not be far behind.

The tardive dyskinesia market race is officially on—and it’s Neurocrine that has the go-ahead to kick things off.

Tuesday, the FDA approved the San Diego drugmaker’s Ingrezza, the first-ever med green-lighted to treat the involuntary movement condition. The company’s field force, which will stand about 160 strong, will kick off the launch around May 1, and it’s then that Neurocrine will disclose the price of its new contender, CEO Kevin Gorman said in an interview.

While there may not be another TD med out there when Ingrezza hits the scene, Neurocrine does have a competitor waiting in the wings--and that’s Teva’s Austedo, approved earlier this month as a Huntington’s therapy. The Israeli drugmaker is currently waiting for its own TD decision from the FDA, and that’s due by late August.

RELATED: Hungry for brand sales, Teva undercuts generics with new, $60K Huntington's med Austedo

As Gorman put it, “we’ll be competitively priced,” with Austedo, which bears a $60,000 price tag that undercut generics in the Huntington’s market. But Neurocrine is hoping a couple key differences between the meds will give Ingrezza a lift.

For one, Gorman said, Teva’s med requires a titration process, with patients starting on a low dose and working their way up “slowly and carefully.” Ingrezza, on the other hand, is a fixed-dose product, with patients receiving either 40 mg or 80 mg—“very simple,” he said. Ingrezza is also dosed once-daily, compared with twice-daily Austedo, a factor that could help improve adherence among a pool of patients that’s traditionally “highly noncompliant.”

And as Evercore ISI analyst Umer Raffat pointed out in a Tuesday note to clients, Austedo bears a black-box warning for depression that Ingrezza doesn’t.

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For now, though, the challenge in front of Neurocrine as a first-to-market competitor is getting awareness out, and that’s a challenge the drugmaker has long been gearing up for. For “well over a year now,” it’s fielded group of 12 medical science liaisons who have been engaging with national and regional opinion leaders to do just that.

A full marketing organization, a brand team, an analytics and operations group and a set of national account managers—who have been meeting with both public and private payers over the course of the last several months—are all also in place. “We’re absolutely ready for launch,” Gorman said.

EP Vantage, for one, predicts that launch has blockbuster potential, pegging the med’s 2022 sales at $1.3 billion.